MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINR, NTRL, 28MM ID, GROUP 1 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number NV GXL LINR, NTRL, 28MM ID, GROUP 1 CUPS

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 01/22/2024

Event Type  Injury  

Manufacturer Narrative

Section d10: concomitant products - element stem c'less w/ha std,12/150mm (cat# 164-01-12 / serial# (b)(6).- novation crown cup no-hole.50mm (cat# 180-00-50 / serial# (b)(6).Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

As reported, approximately nine years post initial left tka, the female patient was revised due to a failed liner.A revision surgery was performed due to liner wear and osteolysis.All components were removed.There was no breakage of device or surgical delay/prolongation.Patient was last known to be in stable condition following the event.No other patient information was reported.Sales rep was unable to obtain photo/x-rays.The device is not available for evaluation due to they were disposed at hospital.

Manufacturer Narrative

H3: the revision reported may have been due to a combination of risk factors specified in the hhe, including but not limited to use error, implant positioning, and patient factors.However, this cannot be confirmed from the reported information and the devices were not available for evaluation.

• Brand Name: NV GXL LINR, NTRL, 28MM ID, GROUP 1 CUPS
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: miguel soza
• MDR Report Key: 18750135
• MDR Text Key: 335892118
• Report Number: 1038671-2024-00279
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K070479
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2019
• Device Model Number: NV GXL LINR, NTRL, 28MM ID, GROUP 1 CUPS
• Device Catalogue Number: 130-28-51
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2024
• Initial Date FDA Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/25/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1729-2022
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female